Izotropic Corporation announced that a notice of allowance has been received from the United States Patent and Trademark office (“USPTO”) for the patent application No. 15/669829, entitled “Measuring Breast Density Using Breast Computed Tomography.” This notice of allowance is the final step before the patent is formally issued.

This patent covers the use of Izotropic Corporation’s dedicated Breast CT Imaging System to measure breast density. Breast CT demonstrates greater accuracy than mammography, the current gold standard for cancer screening and measuring for breast density. This is an important development in the Company’s strategic plan which is expected to provide another competitive advantage and significantly impact both the adoption and use of the Company’s technology in a real-world setting.

Dr. John Boone, Principal Founder and Director, elaborates below. In February 2019, the U.S. Congress ordered the FDA to “establish a national minimum standard to include breast density information in mammography reports”, which would standardize the explanations of “the effect of breast density in masking the presence of breast cancer on a mammogram” in the reports received by patients after mammography imaging tests. More than 30 U.S. states now require personal breast density reporting.

According to the National Cancer Institute (NCI), nearly half of all women age 40 and older who get mammograms are found to have dense breasts. Dense breast tissue appears white on a mammogram–so do suspicious lesions and tumors. The density of the tissue as well as the compression required for mammography and tomosynthesis breast imaging could obscure abnormalities that may otherwise be further investigated if they were observed using these imaging modalities in non-dense breast tissue. Currently, only a mammogram can diagnose and confirm breast density. Dense breast tissue cannot be felt on a clinical or self-breast exam.

"Breast density is important for two reasons (1) women with denser breasts are thought to have a higher risk of breast cancer, and (2) breast cancer is harder to detect using 2D mammography in women with dense breasts. In the world of health care where “personalized medicine” is now a widely accepted priority, an accurate assessment of breast density then sets the stage for designing each individual woman's breast cancer screening protocol.

“Historically, breast density is judged subjectively on two-dimensional mammograms by the interpreting radiologist using a four-point scale. We have shown that the truly 3D volume data sets that are produced using breast CT result in more accurate quantitative estimates of breast density, and this approach significantly outperforms mammography. Therefore, Breast CT may play an important role in quantifying breast density as a woman enters her breast cancer screening years,” says Dr. John Boone, Principal and Founder. “We have also shown using realistic and comprehensive computer simulations that breast CT, owing to its three- dimensional nature, suffers far less in detection probability than two-dimensional mammography in women with dense breasts. Hence, breast CT or the more expensive and time-consuming breast MRI, are likely to be better screening and diagnostic tools in women with dense breasts than 2D mammography.”

The Company will continue to file and prosecute key patents as an integral part of commercializing Breast CT. This welcome development comes weeks after the Company received a notice of allowance from the USPTO for patent application No. 11/913494, entitled “Biopsy Systems for Breast Computed Tomography.” A system based on this intellectual property would give physicians the ability to image and obtain samples of suspicious lesions and tumors for pathology testing using the Company’s Breast CT Imaging System.